IEC 60601-2-3:2012/AMD2:2022
Amendment 2 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
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About This Item
IEC 60601-2-3:2012/AMD2:2022 is a focused amendment to the parent document for medical electrical equipment, adding to the requirements for the basic safety and essential performance of short-wave therapy equipment. For engineering, testing, and procurement teams, it serves as a compliance reference when reviewing product documentation, verification activities, and regulatory preparation for this type of therapeutic device. IEC 60601-2-3:2012/AMD2:2022 should be read together with IEC 60601-2-3:2012, since it modifies and updates that technical baseline rather than acting as a standalone source.
What is IEC 60601-2-3:2012/AMD2:2022?
This amendment supports the technical framework for short-wave therapy equipment used in medical settings, with emphasis on safety and essential performance considerations tied to electrical medical equipment. It is relevant where design review, documented evaluation, and conformity assessment must reflect the current amended requirements. As a supporting document to IEC 60601-2-3:2012, it helps clarify how compliance workflows, test planning, and quality workflows should account for revised expectations in the product file and technical assessment process.
Applications of IEC 60601-2-3:2012/AMD2:2022
Organizations working with short-wave therapy equipment may use IEC 60601-2-3:2012/AMD2:2022 during product development, laboratory evaluation, certification preparation, and procurement review. It is particularly relevant for teams managing technical documentation, verification activities, and risk management for medical electrical equipment that uses short-wave therapy functions. Compliance and testing groups can use it to align engineering validation and product evaluation with the amended safety and performance framework in the parent standard.
Why is IEC 60601-2-3:2012/AMD2:2022 important?
This amendment matters because it helps maintain technical consistency between design intent, test methods, and compliance evidence for short-wave therapy equipment. For manufacturers and laboratories, it supports safer engineering decisions, clearer conformity assessment preparation, and more reliable quality assurance during product review. Using the amended reference can reduce ambiguity in technical documentation and help ensure that safety-related and performance-related expectations are assessed against the current requirements connected to IEC 60601-2-3:2012.
- Supporting amendment for the parent medical electrical equipment document
- Relevant to short-wave therapy equipment safety and essential performance review
- Useful for testing workflows, technical validation, and conformity assessment preparation
- Helps align engineering documentation with updated compliance expectations
- Publication Date: 2022-12-09
- Standard Status: Amendment
- Publisher: IEC
- Edition: 3
- This Version: IEC 60601-2-3:2012 (2022-12-09)
- Previous Version: IEC 60601-2-3:2012 (2016-04-29)
- Previous Version: IEC 60601-2-3:2012 (2012-04-20)
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